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Pharmaceutical Executive December 1, 2010	The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator The European Medicines Agency is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs.
Pharmaceutical Executive September 1, 2014 William Looney	Ireland's Celtic Tiger: Back on the Hunt Leaders from industry, government, and the CRO community examine Ireland's future as a magnet for life science investments, and what the nation must do to remain the leading exporter of finished pharmaceutical products.
Chemistry World August 19, 2013 Hepeng Jia	Chinese drug watchdog set for major reforms China's slow drug approval process has been a cause for complaint for both Chinese subsidiaries of multinational pharmaceuticals and domestic drug developers.
Pharmaceutical Executive October 1, 2005 Lisa Grimes	Clear Road Ahead An industry standard for publicizing clinical-trial results is a ways off. But pharma's openness to more transparent procedures is moving things in the right direction.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
Chemistry World May 8, 2008 Hepeng Jia	China to fast track pioneering drugs China is to speed up the approval of groundbreaking new drugs in an effort to encourage innovation in its pharmaceutical sector, a State Food and Drug Administration (SFDA) official has revealed.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
Chemistry World July 9, 2014 Hepeng Jia	China struggles to speed up drug reviews The China Food and Drug Administration is attempting to outsource some reviewing processes and introducing fast-track priority reviews for selected generic drugs.
Pharmaceutical Executive January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
Pharmaceutical Executive July 1, 2012 William Looney	Today's Mission Critical: Making Sense of Spending on Clinical Trials Mastery of the clinical trial process has become essential to positioning new therapies for leadership in an increasingly crowded and lengthy race to registration.
Pharmaceutical Executive November 1, 2013 Jill Wechsler	Transparency Troubles for Pharma High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise.
Chemistry World May 23, 2012 Andy Extance	Drug watchdogs mark out global territory The US Food and Drug Administration has published plans to ensure that American citizens continue to enjoy access to safe drugs, even as the regulatory pressures of globalization grow.
Pharmaceutical Executive October 1, 2012 Jill Wechsler	Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny.
Pharmaceutical Executive December 1, 2011 George Baeder	China's Future in Bioscience Will big investments in infrastructure carry the day in positioning China as a global drug innovation powerhouse?
Pharmaceutical Executive December 1, 2010 Zhu Shen	China 2020: Walled In No More Pharma sets the pace for China's ambitious new innovation agenda
Pharmaceutical Executive June 1, 2014 Jill Wechsler	Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
Pharmaceutical Executive June 1, 2011	2011 Dealmakers Outlook With Yankee stadium as the backdrop, Pharm Exec convened on March 29 its annual panel of eight business development experts to crack the bat on best practice in licensing for the year ahead.
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
Pharmaceutical Executive October 1, 2006 Clinton & Koroneos	Learn & Confirm At Wyeth, a sweeping set of initiatives is transforming the R&D operation - and spotlighting a possible future for drug development.
Pharmaceutical Executive October 1, 2011	The Essential--and Effective--Bureaucrat Fernand Sauer, First Director General, European Medicines Agency, has witnessed the progressive sterilization of innovative research due to a trend toward ever-larger industry concentration.
The Motley Fool July 11, 2007 Brian Lawler	Not All Pharmaceutical Markets Are the Same The case of China's former FDA leader highlights the issues facing the country's pharmaceutical industry. Investors, take note.
Pharmaceutical Executive February 1, 2006 Sarah Houlton	Global Report: Moving Towards Generic Biologics The European Medicines Agency hopes to complete its guidelines for the approval of biosimilar drugs early this year, paving the way for the approval of biogenerics - and a potential goldmine for the generics companies.
Pharmaceutical Executive April 1, 2012 Feam & Lagus	Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
Pharmaceutical Executive September 1, 2013 William Looney	High Noon For Hot Markets Fading growth, overstretched governments, and a global governance backlash against pharma business are turning up the heat on the performance of emerging country markets.
Pharmaceutical Executive November 1, 2014 William Looney	Pharma Science: It's Hard Amid a resurgence in drug development for hard-to-treat conditions, the bigger question is whether the times are as good for the industry tasked with rendering basic science into therapeutically effective medicines.
Pharmaceutical Executive October 1, 2012 J. Michael Nicholas	Complex Drugs and Biologics: Policy Considerations in Brazil The Brazilian government's policy on biologics doesn't adequately address non-biologic complex drugs. Additional guidance is needed to bring these important medicines to market.
Pharmaceutical Executive January 1, 2009 Jill Wechsler	FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order?
Pharmaceutical Executive August 1, 2008	Harbingers of Change The pharmaceutical industry is changing. Here are eight seminal events that describe how.
Bio-IT World August 13, 2003 John Rhodes	Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert.
Pharmaceutical Executive January 1, 2012 William Looney	Pharma 2012: Hard Times Before the Harvest 2012 will be a transition year for pharma, one of the most important in its history. The challenge is that many new treatments may not complete the move from 'bench to bedside' in time to plug the yawning revenue gap.
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
Chemistry World April 24, 2008 James Mitchell Crow	FDA takes tough line on biologic drug The US Food and Drug Administration has rejected an application from biotechnology firm Genzyme to make its already-approved, protein-based drug Myozyme in larger batches.
Pharmaceutical Executive September 1, 2008 Jill Wechsler	Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches.
Reason October 2007 Ronald Bailey	Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest."
Investment Advisor December 2005 Greg B. Scott	Buying The Future Prudent investing in biotechnology can offer great returns for clients. It's also the wave of the future. Armed with a basic understanding of the dynamics of the industry and the valuation inflection points, intelligent investors can make significant returns.
Chemistry World July 13, 2007 Hepeng Jia	Chinese Legislation to Increase Drug Safety A long-awaited amendment to China's drug registration system is expected to discipline the country's medical sector and boost the pharmaceutical industry.
Pharmaceutical Executive January 1, 2011 Singh & Glozman	Managing Clinical Trials in Emerging Markets Amgen's hub-and-spoke system combines control at home with the flexibility to respond to local needs.
Pharmaceutical Executive June 1, 2012	2012 Dealmakers Outlook With Yankee Stadium as the backdrop, Pharm Exec convened on its annual panel of heavy hitters in business development to crack the bat on best practices in licensing and for the year ahead.
Chemistry World February 14, 2012 Rebecca Trager	FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones.
Pharmaceutical Executive April 1, 2006 Ron Feemster	Thought Leader: Q&A with Joel A. Tune Pharma still enlists contract manufacturers as safety valves, but today's drug developers have also begun to outsource the production of increasingly complicated compounds while they are still in clinical trials.
Pharmaceutical Executive June 1, 2009 John F. Kouten	On the Right Pathways With staggering year-over-year growth, biosimilars are "the future of medicine." Marketers must position their companies for the inevitable changes. President Barack Obama has pledged support for legislation governing biosimilars.
Pharmaceutical Executive June 1, 2006 Jill Wechsler	Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.
Pharmaceutical Executive September 1, 2011 Jill B. Conner	Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs.
Pharmaceutical Executive July 1, 2014 Jill Wechsler	Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace.
The Motley Fool September 23, 2008 Brian Lawler	Will Generic Biologics Get Special Treatment? While the rest of the market was lost in the financial meltdown, a little-noticed report discussing some of the biopharmaceutical bills going through Congress was released.
Pharmaceutical Executive September 1, 2008 Melanie North	Publish or Perish FDAAA means that companies need to register clinical trials; and not only for publication planning.
Pharmaceutical Executive August 1, 2012 Jill Wechsler	Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.
Pharmaceutical Executive August 1, 2012	Sunny Outlook for Biopharm 2020? Albert Wertheimer looks beyond today's dark clouds with a comparatively sunny forecast for the biopharm industry in 2020. Just watch out for the harsh light of complacency.